A kind of high-performance liquid chromatography method for determining fosfomycin sodium impurity

A technology of high-performance liquid chromatography and fosfomycin sodium, which is applied in the direction of measuring devices, instruments, scientific instruments, etc., can solve the problems of fosfomycin sodium impurities such as high polarity, inability to effectively retain, and high separation polarity, and achieve high sensitivity High, improved retention, moderate analysis time

Active Publication Date: 2022-03-15
上海峰林生物科技有限公司
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  • Claims
  • Application Information

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Problems solved by technology

However, the above-mentioned method has many disadvantages, such as the amino column used is relatively fragile, and due to the high polarity of fosfomycin sodium series impurities and the rapid peak generation, it is impossible to effectively retain and separate complex impurity mixed systems with high polarity

Method used

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  • A kind of high-performance liquid chromatography method for determining fosfomycin sodium impurity
  • A kind of high-performance liquid chromatography method for determining fosfomycin sodium impurity
  • A kind of high-performance liquid chromatography method for determining fosfomycin sodium impurity

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Experimental program
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Effect test

Embodiment 1

[0039] 1. Sample preparation

[0040] 1) The test solution:

[0041] Take about 0.05g of fosfomycin sodium, accurately weighed, put in a 50ml measuring bottle, add mobile phase to dissolve and quantitatively dilute to the mark, shake well, filter, and take the subsequent filtrate as the test solution.

[0042] 2) Reference substance solution:

[0043] Accurately weigh an appropriate amount of cis-acrylphosphate sodium reference substance, add mobile phase to dissolve and quantitatively dilute to make a solution containing 0.015 mg of cis-acrylphosphate per 1 ml, shake well, filter, and take the subsequent filtrate as the reference solution.

[0044] 3) System suitability solution:

[0045] Accurately weigh an appropriate amount of sodium allenyl phosphate, sodium cis allenyl phosphate, phenethylamine salt of 2,3-allyl phosphate and sodium trans allenyl phosphate impurity reference substance, and dilute with mobile phase to form a mixed solution of about 10ug / ml.

[0046] 2....

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Abstract

The invention relates to a high-performance liquid chromatography method for determining fosfomycin sodium impurities. The high-performance liquid chromatography method uses a chromatographic column utilizing octadecylsilane bonded silica gel as a filler and adopts a phosphoric acid aqueous solution-methanol mixed solution as a mobile phase, wherein the concentration mass fraction of phosphoric acid in the phosphoric acid aqueous solution is 0.04% to 0.04%. 0.06%, the volume ratio of phosphoric acid aqueous solution to methanol is 99:1~99:5. According to the method of the present invention, the retention of highly polar impurities is enhanced, the complex impurity system of fosfomycin sodium can be effectively separated, and it has good versatility and specificity for specific impurities, high sensitivity, convenient operation, and moderate analysis time. It provides an effective guarantee for the quality control of the compound.

Description

technical field [0001] The invention belongs to the technical field of drug analysis, and in particular relates to a high-performance liquid chromatography method for determining fosfomycin sodium impurities. Background technique [0002] Fosfomycin is a new type of broad-spectrum antibiotic jointly developed by Merck (Merck) of the United States and CEPA of Spain in 1967. It is a phosphoric acid derivative in structure, has a unique chemical structure, and has a small molecular weight. Fosfomycin has a unique mechanism of action, can inhibit the early stage of cell wall synthesis, and does not produce cross-resistance to other antibiotics, and is mainly used to treat Gram-negative and positive bacterial infections. [0003] At present, there are mainly 4 varieties of fosfomycin, namely fosfomycin sodium salt, fosfomycin calcium salt, fosfomycin tromethamine salt, and fosfomycin benzylamine salt. Fosfomycin sodium salt and calcium salt were launched in Europe in 1975, and w...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N30/88G01N30/60
CPCG01N30/88G01N30/60G01N2030/8872
Inventor 郑玉林陈玉双刘丽娟
Owner 上海峰林生物科技有限公司
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